This study is NOT currently recruiting participants.
Number
000744-HG
Sponsoring Institute
National Human Genome Research Institute (NHGRI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 7 Years Max Age: 14 Years
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
Cognitive Training; Mobile App; Neurodevelopmental; fMRI; Brain Training; Smart Games
Recruitment Keyword(s)
Condition(s)
Attention Deficit Hyperactivity Disorder
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Behavioral: Floreo Virtual Reality application Behavioral: Floreo Virtual Reality application - non-adaptive
Supporting Site
National Human Genome Research Institute
Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. A virtual reality-based game may help improve cognitive skills in children with ADHD. It may also help change how the brain functions.
Objective:
To see if a virtual reality-based game helps improve thinking skills and brain function in children with ADHD.
Eligibility:
Children aged 7 to 14 years with ADHD.
Design:
Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Blood or saliva may be collected. Participants may have an MRI scan of the brain.
Participants will receive a set of virtual reality games. The set includes 6 different games played by placing a smartphone inside a virtual reality headset. The participant will play a game for 20 minutes at least 3 days a week for 4 to 6 weeks.
The parent or caregiver will start each game using a tablet. Each of the 6 games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, and sustained attention.
Participants will have interviews each week. They will answer questions about motion sickness, eye strain, or headache.
Blood or saliva tests and the MRI may be repeated after the last game. A 6-month follow-up visit can be by phone or telehealth.
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INCLUSION CRITERIA: In order to be eligible to participate, an individual must meet all of the following criteria: 1. Children must provide informed assent and parents must provide informed consent to participate in the study. 2. Any gender identity, sex assigned at birth or race/ethnicity. 3. Aged between 7 and 14 years of age. 4. Diagnosis of ADHD. All forms of ADHD, including otherwise specified presentation. 5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study. 6. Unmedicated or treated for ADHD with stimulants under a treatment regimen that has been stable for at least four weeks. For the pilot trial, the participants will be 30 children/adolescents with ADHD. All other criteria will be the same as for the main study. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.) 2. History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders. 3. Impairments in uncorrected visual acuity that would interfere with engagement with the VR training. 4. Known to be pregnant. 5. Psychotic disorders (including schizophrenia, psychosis not otherwise specified) or current substance dependence. Participant is considered a suicide risk in the opinion of the PI. 6. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g. limitations in mobility that would render the VR headset unusable).
In order to be eligible to participate, an individual must meet all of the following criteria:
1. Children must provide informed assent and parents must provide informed consent to participate in the study.
2. Any gender identity, sex assigned at birth or race/ethnicity.
3. Aged between 7 and 14 years of age.
4. Diagnosis of ADHD. All forms of ADHD, including otherwise specified presentation.
5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
6. Unmedicated or treated for ADHD with stimulants under a treatment regimen that has been stable for at least four weeks.
For the pilot trial, the participants will be 30 children/adolescents with ADHD. All other criteria will be the same as for the main study.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)
2. History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.
3. Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.
4. Known to be pregnant.
5. Psychotic disorders (including schizophrenia, psychosis not otherwise specified) or current substance dependence. Participant is considered a suicide risk in the opinion of the PI.
6. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g. limitations in mobility that would render the VR headset unusable).
Principal Investigator
Referral Contact
For more information: